Assembly Biosciences' Investigational Herpes Treatment Shows Antiviral Efficacy, Safety In Healthy Participants
Assembly Biosciences' Investigational Herpes Treatment Shows Antiviral Efficacy, Safety In Healthy Participants
Single doses of ABI-5366 at dose levels reached in Phase 1a surpassed Assembly Bio's target plasma concentrations for antiviral efficacy, a target established from PK modeling and projected to reach increased efficacy compared to approved therapies.Assembly Biosciences, Inc. (NASDAQ:ASMB) released interim pharmacokinetic (PK) and safety results from healthy participants in the Phase 1a portion of its ongoing Phase 1a/b study of ABI-5366, an investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate for recurrent genital herpes.
Assembly Biosciences公司（NASDAQ:ASMB）發佈了其正在進行的ABI-5366的Phase 1a/b研究-一項針對反覆發作的生殖器皰疹的研究候選藥物，一項調查性的長效單純皰疹病毒（HSV）解旋酶-引導酶抑制劑的PK和安全性結果。來自健康參與者的中期藥代動力學（PK）和安全性結果。
Due to its extended PK profile, ABI-5366 was well-tolerated and showed a favorable safety profile with exposure of up to 70 days.
由於其擴展的PK剖面，ABI-5366耐受性良好，並且顯示出有利的安全性剖面，暴露時間長達70天。
Also Read: GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech.
此外閱讀：GSK停止研發單純皰疹病毒疫苗，爲Moderna、BioNTech等其他競爭者鋪平道路。
Single doses of ABI-5366 at dose levels reached in Phase 1a surpassed Assembly Bio's target plasma concentrations for antiviral efficacy, a target established from PK modeling and projected to reach increased efficacy compared to approved therapies.
在Phase 1a中達到的ABI-5366單劑量超過了Assembly Bio針對抗病毒功效的目標血漿濃度，該目標是從PK建模製定的，並預計將比已批准的治療更加有效。
ABI-5366's half-life across the doses evaluated to date of approximately 20 days when dosed orally supports the company's once-weekly oral dosing target and the evaluation of a once-monthly oral dosing profile.
到目前爲止評估的ABI-5366劑量中，口服給藥的半衰期約爲20天，支持公司的一週一次口服給藥目標以及一月一次口服給藥剖面的評估。
"With the exceptional oral half-life of ABI-5366, we look forward to exploring its potential for both once-weekly and once-monthly oral dosing. To that end, we initiated screening for the Phase 1b portion of the study in participants with recurrent genital herpes and expect to report interim results in the first half of 2025," said Jason Okazaki, CEO of Assembly Bio.
「由於ABI-5366出色的口服半衰期，我們期待探索其一週一次和一月一次口服給藥的潛力。爲此，我們已啓動對參與者進行反覆發作性生殖器皰疹的研究10億部分的篩選，並預計將於2025年上半年報告中期結果，」Assembly Bio的首席執行官Jason Okazaki表示。
ABI-5366 was well-tolerated, and a favorable safety profile was observed with exposure of up to 70 days.
ABI-5366耐受性良好，暴露時間長達70天，觀察到有利的安全性剖面。
Treatment-emergent adverse events (AEs) were mild to moderate in intensity and considered not related to study treatment by the study investigators; there were no serious AEs in any dose arm.
治療相關的不良事件（AEs）在強度上從輕到中等，並被研究調查人員認爲與研究治療無關；在任何劑量區域均無嚴重的不良事件。
Interim results exceeded Assembly Bio's objectives for this Phase 1a study and support ABI-5366's progression into Phase 1b.
中間結果超過了Assembly Bio在本階段1a研究中的目標，並支持ABI-5366進入第十億階段。
Assembly Bio has initiated screening for Part B (Phase 1b) in participants seropositive for HSV-2 with recurrent genital herpes, which will evaluate multiple ascending doses of ABI-5366.
Assembly Bio已經開始爲HSV-2抗體陽性且患有反覆性生殖器皰疹的受試者篩選第b部分（1b期），將評估ABI-5366的多劑量遞增。
Part B of the study will evaluate weekly and monthly oral regimens of ABI-5366 over a 29-day treatment interval in four cohorts.
該研究的b部分將評估ABI-5366的每週和每月口服方案，爲期29天，分爲四個隊列。
In addition to assessing safety, tolerability and PK, Part B will also evaluate antiviral activity by assessing changes in viral parameters.
除了評估安全性、耐受性和PK，b部分還將通過評估病毒參數的變化來評估抗病毒活性。
Price Action: ASMB stock is down 9.42% at $17.60 at last check Monday.
價格行動：ASMb股票在上週一最後覈查時跌至17.60美元，下跌9.42%。
Photo via Shutterstock
圖片來自shutterstock。
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譯文內容由第三人軟體翻譯。
